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The powerful chairman of the Senate Finance Committee introduced legislation yesterday that would make it legal to import drugs from Canada. “Free trade principles argue for allowing importation of drugs from Canada and other countries as long as those drugs are safe,” said Sen. Chuck Grassley (R-Iowa).
The FDA has given generic drugmakers Sandoz and Three Rivers Pharmaceuticals the green light to market the first equivalent versions of Schering-Plough’s hepatitis C drug Rebetol (ribavirin) in 200-mg strength capsules, the firms said yesterday.
Generic firm Mylan Pharmaceuticals will be able to launch a version of Johnson & Johnson’s (J&J’s) pain drug patch Duragesic (fentanyl) when the patent expires July 23 as long as it meets the requirements of its abbreviated new drug application, the FDA said yesterday.
Rather than curtailing services, the FDA plans to consolidate the agency’s 16 existing drug review centers into just three centers at the White Oak campus in Maryland, which should increase productivity and boost performance, according to an FDA spokesperson.
The FDA has issued a revised guidance to help drugmakers determine how they should report postapproval manufacturing changes to new drug applications (NDAs) or abbreviated new drug applications (ANDAs).
Generic firm Mylan Pharmaceuticals says Johnson & Johnson’s subsidiary Alza is not entitled to six months of pediatric exclusivity on its pain drug patch Duragesic (fentanyl) because the firm failed to sue Mylan for patent infringement within the required 45-day notification period.
In a case that could clarify the controversial declaratory judgment provision of last year’s drug patent law, the FTC is urging a federal appeals court to reverse a lower court’s dismissal of generic firm Teva Pharmaceutical’s filing challenging the validity of Pfizer’s patent for the antidepressant Zoloft (sertraline HCl).
In a move to block generic competition by an additional six months, Bristol-Myers Squibb (BMS) March 31 filed data with the FDA from two clinical studies involving the pediatric use of its profitable cancer drug Paraplatin (carboplatin).